MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION X SERIES; DEFIBRILLATOR/PACEMAKER

Model Number	X SERIES
Medical Device Problem Codes	Failure to Deliver Shock/Stimulation (1133); Delayed Charge Time (2586)
Health Effect - Clinical Code	Necrosis (1971)
Date of Event	11/15/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to defibrillate an (b)(6) female patient, the device took an extended time to charge energy and failed to discharge.They were unable to convert the rhythm for approximately 5 min until the transport ambulance arrived and placed the patent on their monitor.Complainant indicated that the patient subsequently expired.
Additional Manufacturer Narrative
The device was not returned to zoll medical corporation for evaluation.Instead, the device clinical event data log was provided for review.The customer's report was observed and the log confirmed that the device could not fully charge.The first two charge attempts were manually dumped by the user.The next two charge attempts, the device did not fully charge and responded with charging errors that indicated the charging was too slow.There was no evidence in the log that the device ever reached a full charge, or that the battery was replaced.Without receipt of the device and battery used, root cause cannot be established.No device hardware faults are observed in the log outside the advisories.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: X SERIES
• Common Device Name: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 12972074
• Report Number: 1220908-2021-04214
• Device Sequence Number: 11807158
• Product Code: MKJ
• UDI-Device Identifier: 00847946018177
• UDI-Public: 00847946018177
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K112432/P160
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: X SERIES
• Device Catalogue Number: X SERIES
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 12/09/2021
• Supplement Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 84 YR
• Patient Sex: Female